Premix 70/30 Insulin Plus Supplemental Lunch Insulin in Comparison to Basal Plus Prandial Supplemental Scale and Sliding Scale Insulin in Hospitalized Patients With Type 2 Diabetes
| Registry | NCT01855243 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 63 (Actual) |
| Sponsor | Cairo University (Other) |
| Conditions | Diabetes Mellitus (DM) |
| Interventions | regular insulin, 70/30 insulin, Glargine, glulisine (Drug) |
| Dates | start 2010-03-01, primary completion 2014-02-01, completion 2014-06-01, first posted 2013-05-16, last updated 2019-01-15 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Diabetes Mellitus (DM) All trials of regular insulin All trials of 70/30 insulin
Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes.
Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| glargine plus supplemental glulisine | Active comparator | Drug: Glargine; Drug: glulisine | Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. |
| 70/30 insulin plus supplemental lunch insulin | Active comparator | Drug: regular insulin; Drug: 70/30 insulin | Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. |
| Sliding Scale insulin (SSI) | Active comparator | Drug: regular insulin | For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table |
Sex: All, ages: 18 Years to 64 Years
Inclusion Criteria: * known history of type 2 DM for longer than 3 months * age between 18-64 year old, * treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission. Exclusion Criteria: * subjects with hyperglycemia without any known history of DM * presence of diabetic ketoacidosis (DKA) * patients admitted to intensive care unit (ICU) * subjects expected to undergo surgery during the hospitalization course * patients with clinically relevant hepatic disease impaired renal function (serum creatinine ≥ 3.0 mg/dL) systemic infections pregnancy patients on medications known to interfere with the blood glucose level (either increasing or decreasing
| Milestone | Glargine Plus Supplemental Glulisine | 70/30 Insulin Plus Supplemental Lunch Insulin | Sliding Scale Insulin (SSI) |
|---|---|---|---|
| Started | 20 | 21 | 22 |
| Completed | 19 | 21 | 22 |
| Not completed | 1 | 0 | 0 |
Time frame: during hospital stay which is expected to be 3 weeks
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Glargine Plus Supplemental Glulisine | 0 | 2/19 (10.5%) | 10/19 (52.6%) |
| 70/30 Insulin Plus Supplemental Lunch Insulin | 0 | 0/21 (0.0%) | 4/21 (19.0%) |
| Sliding Scale Insulin (SSI) | 0 | 0/22 (0.0%) | 15/21 (71.4%) |
| Term | Organ system | Glargine Plus Supplemental Glulisine | 70/30 Insulin Plus Supplemental Lunch Insulin | Sliding Scale Insulin (SSI) |
|---|---|---|---|---|
| major hypoglycemia | Nervous system disorders | 2/19 | 0/21 | 0/22 |
| Term | Organ system | Glargine Plus Supplemental Glulisine | 70/30 Insulin Plus Supplemental Lunch Insulin | Sliding Scale Insulin (SSI) |
|---|---|---|---|---|
| Severe Hyperglcemia eposide | Nervous system disorders | 10/19 | 4/21 | 15/21 |
Limitations and caveats: self funded
| Facility | City | Country | Status |
|---|---|---|---|
| the department of internal medicine, Cairo University teaching hospitals, | Cairo | Egypt |